EkoSonic® 6779-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00858593006189), received between Apr 11, 2017 and Oct 14, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH/MAUDE REPORT LIST #MW5158934 THAT THERE WAS A DRUG LEAK. AN EKOSONIC ENDOVASCULAR DEVICE, 106X50CM WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TPA ADMINISTRATION WAS STARTED, A SMALL LEAK WAS DISCOVERED IN THE CATHETER. NO FURTHER DETAILS WERE AVAILABLE, DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441985 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THIS 106X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A THROMBOLYSIS PROCEDURE. DURING INSERTION OF THE DEVICE, IT WAS EASILY ADVANCED; HOWEVER, THEN THE ULTRASONIC CORE FRACTURED. THE DEVICE WAS REMOVED AND REPLACED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528895 ↗
• MalfunctionAug 22, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE ULTRASONIC CORE (USC) FRACTURED INTERNALLY. AN EKOSONIC ENDOVASCULAR DEVICE, 106X50CM WAS SELECTED FOR USE TO TREAT A PULMONARY EMBOLISM. THE INFUSION CATHETER (IC) WAS PLACED WITHOUT ISSUE. WHEN THE USC WAS ADVANCED INTO THE IC, THERE WAS RESISTANCE ENCOUNTERED. THE USC FRACTURED WITHIN THE IC. ALL PIECES OF THE USC WERE REMOVED SUCCESSFULLY. THE USC WAS REPLACED TO COMPLETE THE PROCEDURE AND THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596684 ↗
• InjuryMar 30, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH/MAUDE REPORT LIST # MW5115243 THAT THE EKOSONIC THROMBOLYSIS CATHETER FRACTURED INSIDE OF THE PATIENT AND THE DEVICE FRAGMENT HAD TO BE RETRIEVED BY THE PHYSICIAN. AN EKOSONIC THROMBOLYSIS CATHETER WAS SELECTED FOR USE. AFTER THE DEVICE WAS PLACED, THE PATIENT BENT THEIR LEG, CAUSING THE EKOSONIC THROMBOLYSIS CATHETER TO FRACTURE INSIDE THE VEIN. THE PHYSICIAN HAS TO RETRIEVE THE FRACTURED PIECE OF THE CATHETER FROM THE PATIENT. NO FURTHER ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED UNDER FLUOROSCOPY. ONCE THE PATIENT WAS IN THE ICU, ONE HOUR THE DEVICE WAS PLACED, THE EKOSONIC ENDOVASCULAR DEVICE STOPPED WORKING, THE PHYSICIAN REMOVED THE ULTRASONIC CORE (USC) IN THE ICU WITHOUT THE USE OF FLUOROSCOPY AND REPLACED IT WITH ANOTHER USC OF THE SAME SIZE. THE PATIENT'S LEG WAS THEN PUT INTO A LEG FIXATION DEVICE AND REMAINDER OF THERAPY WAS DELIVERED. ONCE THE PATIENT WAS BROUGHT BACK FOR THE FINAL FLUOROSCOPY, THE PHYSICIAN REALIZED THAT THE FIRST USC HAD FRACTURED AND WAS PUSHED OUT BY THE SECOND USC. THE DETACHED PORTION OF THE USC WAS RETRIEVED, AND THE PATIENT HAD A GOOD OUTCOME

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643926 ↗
• MalfunctionJun 11, 2020Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  IT WAS REPORTED THAT DURING THE USE OF AN EKOSONIC DEEP VEIN THROMBOSIS (DVT) CATHETER, DISPLAYED THE DEVICE TEMPERATURE TOO HIGH ALARM. THE ISSUE WAS ABLE TO BE RESOLVED THROUGH TROUBLESHOOTING AND THERAPY WAS RESTARTED. NINE HOURS LATER, THE TEMPERATURE TOO HIGH ALARM OCCURRED AGAIN. TROUBLESHOOTING WAS UNSUCCESSFUL AND ULTRASOUND WAS TURNED OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142666 ↗
• MalfunctionApr 23, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE MICROSONIC DEVICE (MSD) CATHETER WOULD NOT RUN ANY LONGER THAN ONE MINUTE DURING A DVT CASE. NO FLUID INGRESS OR BENT PINS WAS FOUND BY THE CUSTOMER DURING TROUBLESHOOTING. THE CONTROL UNIT (CU) AND CONNECTOR INTERFACE CABLE (CIC) WAS EXCHANGED DURING TROUBLESHOOTING, BUT THE ISSUE DID NOT RESOLVE. THE MSD WAS REMOVED AND REPLACED WITH A NEW ONE. NO ISSUES WERE ENCOUNTERED AFTER EXCHANGING THE MSD. THE PATIENT WAS REPORTED TO BE DOING FINE. ON 13 APRIL 2020 A SHORT WAS NOTED IN THE HUB OF THE MSD DURING INVESTIGATION OF THE RETURNED DEVICE. THIS WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989392 ↗
• MalfunctionOct 14, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE NURSE CALLED THE EKOS HELPLINE THREE TIMES TO REPORT DEVICE TEMPERATURE TOO HIGH ALARM. FIRST TIME, TROUBLESHOOTING REVEALED A LOOSE CONNECTION. THE SECOND TIME, THE DEVICE ALARMED BECAUSE THE CONNECTOR INTERFACE CABLE WAS UNDER THE BLANKETS. THE THIRD TIME, THE NURSE CALLED BACK WITH ANOTHER DEVICE TEMP TO HIGH ALARM. THERAPY HAD BEEN RUNNING FOR 29 HOURS. THE PHYSICIAN INSTRUCTED TO STOP THE TPA BECAUSE HE THOUGHT MOST OF THE CLOT WAS DISSOLVED. KVO FLUIDS WERE RUN THROUGH BOTH THE COOLANT AND THE DRUG PORT. PATIENT WAS REPORTED AS OKAY. THE NEXT DAY, PER HOSPITAL PROTOCOL FOR DVT CASES, THE PATIENT UNDERWENT A FOLLOW-UP PROCEDURE. ACCESS WAS ESTABLISHED IN LEFT POPLITEAL VEIN (PREVIOUS ACCESS WAS FROM A TIBIAL VEIN) AND PATIENT WAS PLACED PRONE. IMAGES OF THE LEFT COMMON FEMORAL VEIN SHOWED IT OPEN, BUT SOME LARGE CLOTS WERE STILL PRESENT IN THE ILIAC VEIN EXTENDING INTO THE INFERIOR VENA CAVA (IVC). TO ADDRESS THE REMAINING CLOTS IN THE IVC AND ILIAC, THE PHYSICIAN USED A CLOTTRIEVER DEVICE FROM (B)(4). HE MADE SEVERAL PASSES WITH THE DEVICE AND REMOVED MANY CLOTS. FOLLOW UP VENOGRAM POST INARI SHOWED SOME IMPROVEMENT IN CLOT BURDEN IN ILIAC. IVC STILL HAS SLUGGISH FLOW WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187290 ↗
• MalfunctionJul 25, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, 3 HOURS AND 3 MINUTES INTO THERAPY, THE ACCOUNT CALLED WITH AN ALL MSD GROUPS DISABLED ALARM, ALL FIVE BARS WERE GREY. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PHYSICIAN WAS NOTIFIED OF EKOS BEING OFF AND TO CONTINUE INFUSIONS. PATIENT WAS DOING GOOD. THE DEVICE WAS PLACED IN A BILATERAL DVT CASE ON (B)(6) 2019 AND WAS ON DAY TWO OF THE THERAPY. THE CATHETER WAS REMOVED ON (B)(6) 2019. PER THE PHYSICIAN, THE PATIENT OUTCOME WAS GOOD. THE PHYSICIAN ALSO INFORMED THAT THE CATHETER WAS REMOVED AND COILED UP TIGHTLY BEFORE PUTTING IT BACK IN THE PATIENT WHICH MAY HAVE DAMAGED THE MSD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ON (B)(6) 2019, INVESTIGATION FOUND THAT THE MSD WAS PULLED APART DISTAL OF THE CLEAR STRAIN RELIEF AND A TEAR WAS FOUND IN THE IDDC DRUG LUMEN ALLOWING LEAKING FROM THAT LUMEN. WHILE NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED, SERIOUS INJURY COULD OCCUR IF THIS MALFUNCTION WAS TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8827459 ↗
• MalfunctionApr 29, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, A HELPLINE CALL REPORTED A "MSD NOT FUNCTIONAL" ALARM AFTER A UNILATERAL DVT PROCEDURE. THE MSD HAD GONE IN SMOOTHLY. THE ALARM WAS NOT RESOLVED. TREATMENT PROCEEDED WITH USING THE EKOS CATHETER AS A CATHETER-DIRECTED THROMBOLYSIS/WITH LYTIC ONLY (CDT). THE ICU NURSE REPORTED THAT A STAT-LOCK TYPE OF DEVICE WAS USED TO HOLD CATHETER IN PLACE. WHEN FLUIDS WERE HOOKED UP, THE SYSTEM SOUNDED A DOWNSTREAM OCCLUSION ALARM ON THE IV PUMP. THE NURSE HAD TO REMOVE THE "STAT-LOCK" TO GET FLUIDS TO RUN. THE PATIENT WAS REPORTEDLY FINE AND STABLE. ON (B)(6), THE TERRITORY MANAGER REPORTED THAT, DURING FOLLOW-UP, A VENOGRAM SHOWED THAT THERE WAS STILL THROMBUS IN THE COMMON FEMORAL DOWN TO THE POPLITEAL. THE PHYSICIAN USED ANGIOJET WHICH CLEARED THE REST OF THE THROMBUS. THE PATIENT WAS TAKEN BACK TO ICU IN GOOD CONDITION.

  Patient problems: No Code Available

  MAUDE report 8560727 ↗
• MalfunctionFeb 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WITH A PERIPHERAL ARTERIAL OCCLUSION WAS TREATED WITH EKOS (S/N: (B)(4)) ON (B)(6) 2019. WHILE ADVANCING THE MSD DURING PLACEMENT, RESISTANCE WAS FELT. THE PHYSICIAN PULLED THE MSD OUT, REFLUSHED THE WIRE LUMEN AND THEN ATTEMPTED TO ADVANCE THE MSD AGAIN. RESISTANCE WAS VERY SIGNIFICANT AND THE MSD KINKED. THE PHYSICIAN DECIDED TO REMOVE IT. UPON REMOVAL, THE PROXIMAL END OF THE MSD WAS BROKEN. THERE WAS A LOT OF THE MSD STILL WITHIN THE IDDC. THE PHYSICIAN CUT THE IDDC RIGHT AT THE STRAIN RELIEF TO EXPOSE THE WIRE LUMEN AND PULLED OUT THE MSD THE PHYSICIAN WAS ABLE TO MAINTAIN ACCESS AND START OVER WITH ANOTHER 0.035" WIRE THROUGH THE CUT EKOS LUMEN TO MAINTAIN POSITION. HE THEN REMOVED THE IDDC AND PLACED A CRAGG-MCNAMARA OVER THE WIRE AND INTO POSITION. THE PATIENT WAS REPORTED TO BE STABLE AND SLEPT THROUGH THE PROCEDURE. NO PIECES WERE LOST IN THE PATIENT, THE FRACTURED MDS SECTION WAS REMOVED SUCCESSFULLY. THE PATIENT WAS BEING TRANSFERRED TO ICU FOR LYTIC THERAPY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359482 ↗
• MalfunctionFeb 5, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WITH A UNILATERAL LEFT SFA OCCLUSION WAS TREATED WITH EKOS ON (B)(6) 2018. DURING THERAPY, AN OVER TEMP ALARM OCCURRED FOLLOWED BY A 'ALL GROUPS DISABLED' ALARM. THE PATIENT DID RECEIVE THE FULL DOSE OF THERAPY AND WAS REPORTED AS DOING WELL. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307815 ↗
• MalfunctionMay 17, 2018Smoking; Smoking

  DURING COMPLAINT FOLLOW UP COMMUNICATION, IT WAS REPORTED THAT UPON FINAL REMOVAL OF THE MSD, THERE WAS VISIBLE SMOKE. IT WAS REPORTED THAT THE ULTRASOUND WAS STILL ON WHILE THE MSD WAS BEING REMOVED FROM THE PATIENT. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED IN ASSOCIATION WITH THE VISIBLE SMOKE. THE MSD WAS DISCARDED BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522415 ↗
• MalfunctionMay 7, 2018Fracture; Fracture

  IT WAS REPORTED THAT A 50 CM EKOS CATHETER WAS USED TO TREAT A PATIENT WITH A UNILATERAL ARTERIAL OCCLUSION ON (B)(6) 2018. THE CATHETER RAN ONE HOUR AND 39 MINUTES. WHEN IT WAS PULLED OUT, IT WAS DISCOVERED THE MSD WAS FRACTURED INSIDE THE IDDC. THE 50CM CATHETER WAS REPLACED WITH A 30CM THAT RAN FOR 20 HOURS AND IT WAS REPORTED THAT THE PATIENT DID FINE. THE PATIENT WAS NOT HARMED AS A RESULT OF THE FRACTURED MSD. UPON INVESTIGATION OF THE RETURNED DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED BY DEVICE DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492335 ↗
• MalfunctionFeb 27, 2018Fracture; Detachment of Device or Device Component; Electrical Shorting; Fracture; Detachment of Device or Device Component; Electrical Shorting

  IT WAS REPORTED THAT FOLLOWING THE END OF A PATIENT TREATMENT, UPON REMOVAL OF THE CATHETER, THE DISTAL END OF THE CATHETER WAS BENT AT A RIGHT ANGLE. AS SOON AS THE USER TOUCHED THE MSD, THE DISTAL END FELL OFF. UPON INVESTIGATION OF THE RETURNED DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298766 ↗
• MalfunctionFeb 8, 2018Electrical Shorting; Electrical Shorting

  ON (B)(6) 2017, A HELPLINE CALL REPORTED A TEMPERATURE ALARM AFTER 16 HOURS AND 40 MINUTES OF THERAPY. THE ALARM WAS RESOLVED OVER THE PHONE WITH THE EKOS REPRESENTATIVE BY INCREASE THE COOLANT RATE THROUGH THE DEVICE. THE DEVICE WAS RETURNED TO EKOS FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7254802 ↗
• MalfunctionJul 13, 2017Fracture; Device Inoperable; Device Handling Problem; Fracture; Device Inoperable; Device Handling Problem

  A 106CM/50CM EKOSONIC CATHETER (SN: (B)(4)) WAS USED TO TREAT A PATIENT WITH PERIPHERAL ARTERIAL OCCLUSION IN EARLY (B)(6) 2017, EXACT EVENT DATE WAS NOT PROVIDED. AFTER SUCCESSFULLY PLACED INFUSION CATHETER (PART OF THE EKOSONIC CATHETER) IN THE PATIENT, THE TREATING PHYSICIAN TRIED TO PLACE ULTRASOUND CORE ( MICROSONIC DEVICE) AND THE ULTRASOUND CORE WIRE FRACTURED INSIDE THE INFUSION CATHETER. THE PHYSICIAN REMOVED THE CATHETER AND PLACED ANOTHER EKOS DEVICE WITH NO FURTHER ISSUES. THE PATIENT WAS NOT HARMED AND LYSED COMPLETELY AFTER NEW 50CM DEVICE WAS PLACED IN POSITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710728 ↗
• MalfunctionJul 12, 2017Bent; Material Deformation; Material Twisted/Bent; Bent; Material Deformation; Material Twisted/Bent

  A NURSE, SUPPORTING THE CASE, REPORTED THAT THE MICROSONIC DEVICE (MSD; ULTRASOUND WIRE) DID NOT ADVANCE THE CATHETER AND THE TREATING PHYSICIAN WAS UNABLE TO PLACE AND LOCK DUE TO RESISTANCE. SHE REPORTED THAT THE TREATING PHYISICIAN OPENED A SIMILAR DEVICE (30CM) AND PLACED IT EASILY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6709515 ↗
• MalfunctionJul 11, 2017Fracture; Device Inoperable; Device Handling Problem; Fracture; Device Inoperable; Device Handling Problem

  A 106CM/50CM EKOSONIC CATHETER (SN: (B)(4)) WAS USED TO TREAT A PATIENT WITH PERIPHERAL ARTERIAL OCCLUSION ON (B)(6) 2017. AFTER SUCCESSFULLY PLACED INFUSION CATHETER (PART OF THE EKOSONIC CATHETER) IN THE PATIENT, THE TREATING PHYSICIAN TRIED TO PLACE ULTRASOUND CORE (THE MICROSONIC DEVICE) AND THE ULTRASOUND CORE WIRE FRACTURED INSIDE THE INFUSION CATHETER. THE PHYSICIAN WAS ABLE TO RETRIEVE ULTRASOUND CORE BY PULLING OUT THE INFUSION CATHETER AND REPLACING WITH ANOTHER EKOS DEVICE. THE PROCEDURE WAS COMPLETED AND PATIENT WAS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6704798 ↗
• MalfunctionApr 11, 2017Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  ON (B)(6) 2017 DURING A PERIPHERAL ARTEIAL OCCLUSION PROCEDURE USING A CONTRALATERAL APPROACH OVER THE ILIAC BIFURCATION UP AND OVER TO TREAT THE PROXIMAL COMMON FEMORAL GRAFT TO POPLITEAL, THE PHYSICIAN REPORTED THAT HE EXPERIENCED PROBLEMS ADVANCING THE MSD. THE IDDC WAS PLACED WITH NO ISSUES, HOWEVER THE PHYSICIAN NOTED RESISTANCE WHILE TRYING TO ADVANCE THE MSD. IT WAS NOTED BY THE EKOS REP THAT THIS CASE HAD TORTUOUS ANATOMY AND WAS AN "UNCOMMON CASE". THE PHYSICIAN THEN TRIED TO PLACE ANOTHER EKOS CATHETER OF THE SAME SIZE. THE IDDC OF THE SECOND CATHETER ALSO PLACED EASILY BUT THE MSD BECAME DIFFICULT TO TRACK BEYOND THE BIFURCATION. ADDITIONAL FOLLOW-UP FROM THE EKOS FIELD REPRESENTATIVES ON (B)(6) 2017 INDICATED THAT UPON ATTEMPTING TO ADVANCE THE SECOND MSD SEVERAL TIMES, THE PHYSICIAN WAS UNABLE TO DO SO. THE LAST TIME HE ATTEMPTED TO PUSH THE WIRE IN, IT FRACTURED. ENOUGH WIRE WAS STICKING OUT OF THE IDDC HUB THAT THE PHYSICIAN WAS ABLE TO REMOVE IT USING A HEMOSTAT. IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THERE WAS NOTHING LEFT IN THE CATHETER. THE PHYSICIAN THEN PLACED A FLOW SWITCH AT THE MSD CONNECTION AND USED THE EKOS IDDC AS AN INFUSION CATHETER ONLY. FOUR HOURS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6483681 ↗